|Company name||TherapeuticsMD, Inc.|
|Class period||July 7, 2016 to April 9, 2017|
|Lead plaintiff deadline||June 16, 2017|
|Court||Southern District of Florida|
NEW YORK, April 19, 2017 – Bragar Eagel & Squire, P.C. announces that a class action lawsuit has been filed in the United States District Court for the California Central District Court on behalf of all persons or entities who acquired Endologix, Inc. (NASDAQ: ELGX) securities between July 7, 2016 and April 9, 2017 (the “Class Period”).
According to the Complaint, on July 7, 2016, the Company announced that it had filed its New Drug Application (“NDA”) for TX-004HR with the U.S. Food and Drug Administration (“FDA”) seeking approval of TX-004HR for the treatment of moderate to severe dyspareunia. The Company subsequently stated that it was making excellent progress and that it was encouraged by its positive pivotal Phase 3 Rejoice Trial designed to assess the safety and efficacy of TX-004HR. The Complaint alleges that the company failed to inform investors that its NDA submission was deficient and was not supported by the complete TX-004HR clinical program, which would likely cause a delay of the FDA’s potential approval of the NDA.
On April 10, 2017, TherapeuticsMD issued a press release revealing that, as part of its ongoing review of the NDA, the FDA “identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time.” The Company further stated that the letter did not specify the deficiencies and that the company was not aware of the nature of the deficiencies. TherapeuticsMD noted that the FDA had previously set a target date of April 9, 2017, for communicating to the company proposed labeling and postmarketing requirements and commitments.
If you purchased or otherwise acquired TherapeuticsMD securities during the Class Period and suffered a loss or continue to hold shares purchased prior to the Class Period, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Esq. by email at firstname.lastname@example.org, or telephone at (212) 355-4648, or by filling out the contact form below. There is no cost or obligation to you.